Cleared Traditional

K153723 - ACTICOAT Surgical Dressing

K153723 · Smith & Nephew Medical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
261d
Days
-
Risk

K153723 is an FDA 510(k) clearance for the ACTICOAT Surgical Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on September 14, 2016 after a review of 261 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K153723

510(k) Number K153723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date September 14, 2016
Days to Decision 261 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 341
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K153723.
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016
Exufiber Ag+
K160379 · Molnlycke Health Care Us, LLC · Aug 2016
LUOFUCON Silicone Ag foam dressing
K160022 · Huizhou Foryou Medical Devices Co., Ltd. · Aug 2016
DURAFIBER Ag
K161289 · Smith & Nephew Medical Limited · Aug 2016